RETeval All Comers Trial (REACT)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any - 95
Updated:3/8/2017
Start Date:February 13, 2017
End Date:April 2018
Contact:Olga Kraszewska, PhD
Email:olgakraszewska.phd@gmail.com

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The primary objective of this study is to collect electroretinogram ERG measurements from
visually normal and abnormal subjects using the FDA cleared RETeval device (K142567). Data
from the visually normal subjects will be used to create reference intervals for the device.
Secondary objectives of the study are to provide ERG waveforms representative of disease
states encountered and to analyze how well an ERG detects the various disease states
encountered.


Inclusion Criteria:

- All volunteers (age 0.5 to 95) willing to participate in the study as a part of their
routine eye exam.

- While not specifically targeting vulnerable groups such as for example children and
pregnant women, we invite them to participate in the study. Collecting normative data
from these less represented populations is particularly difficult and we welcome the
opportunity to gather these rare data.

- Subjects under the age of 18 will be included with the assent of the subject (for
those at least 10 years of age) and consent from one parent/guardian (for those under
age of 10).

- In any case patient is not able to provide the consent by him/her self and is willing
to participate in the study the same person that is consenting for the routine eye
exam can consent for the REACT study.

Exclusion Criteria:

- Subjects with photosensitive epilepsy , allergies to pupil dilating agents, or
history of cardiac dysrhythmia will not be invited to participate in this study. -
Subjects with history of glaucoma can either be included in the group of non dilated
subjects or can have dilated ERGs if the dilation was recommended by the health
professional as the part of the routine eye exam.

- Exclusion criteria will be based on volunteer's providing this information at the
time of signing the consent form.

- If patient is not aware of his photosensitive epilepsy and it occurs during the
recording, the test will be interrupted immediately.

- Statistically, 1 person out of 3600 people can suffer from photosensitive epilepsy in
US.

- There is a rather small possibility we will encounter such a person during the
collection of ERGs from the group of 1000 volunteers
We found this trial at
1
site
1530 Bedford Avenue
Brooklyn, New York 11216
Phone: 682-551-2601
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Brooklyn, NY
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